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. 2016 Jun 21;2016(6):CD010696. doi: 10.1002/14651858.CD010696.pub2

Salami 1984.

Study characteristics
Methods Allocation: randomised, but no further information
Design: parallel‐group
Participants Number: 30 randomised
Age: mean 46 (SD 4)
Gender: 17 M, 13 F
Setting: Italy
Eligibility criteria: Ménière's disease, clinically defined
Exclusion criteria: other causes of vertigo
Baseline characteristics: groups similar at baseline
Interventions Betahistine 8 mg 3 times a day versus placebo over 6 weeks
Intervention group:
n = 15
Comparator group:
n = 15
Use of additional interventions: none
Outcomes Primary outcome: vertigo intensity on a 4‐point scale
Secondary outcomes: vestibular function tests (electronystagmography and caloric testing)
Funding sources Not stated
Declarations of interest Not stated
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomised"; no further information
Allocation concealment (selection bias) Unclear risk Method not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Double‐blind, but no further information
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Double‐blind, but no further information
Incomplete outcome data (attrition bias)
All outcomes Low risk No attrition (James 2001)
Selective reporting (reporting bias) Low risk Outcomes and adverse events reported
Other bias Unclear risk

AAO‐HNS: American Academy of Otolaryngology – Head and Neck Surgery
BPPV: benign paroxysmal positional vertigo
CNS: central nervous system
ENG: electronystagmogram
ENT: ear, nose and throat
F: female
M: male
MD: Ménière's disease
MS: multiple sclerosis
SD: standard deviation